Medicines, 2013
Shortlist up to four to read them side by side.
1,376 medicine recalls FDA’s Enforcement Report published in 2013, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
1,376of 1,376 medicine recallsshown with your filters
The list
- Medicine recall Believe in Yourself Strawberry Anti bac Justice, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Share a Smile Mixed berry Anti bac Justice, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Shine from within blueberry Anti bac Justice, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Girls can change the World, Green Apple Anti bac Justice, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall FOLLOW YOUR DREAMS! Justice, Chocolate anti bac, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall TODAY IS AWESOME! Justice, Cotton Candy anti bac, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall LIFE IS SWEET! Justice, Vanilla Scent anti bac, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall I love my BFF Justice, Watermelon anti bac, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall I love sleep overs Justice, Grape anti bac, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall I love to shop Justice, Peach anti bac, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lemon anti bac Justice, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Grapefruit anti bac Justice, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall GIRLS ROCK Justice, VANILLA scent anti bac, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall I LOVE BACON Justice, VANILLA scent anti bac, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall YOU CANT HANDLE THIS Justice, GRAPE SCENT ANTI BAC, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall yum yum bubble gum Justice, BUBBLEGUM SCENT ANTI BAC, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall BFF’s are COOL! Justice, CHERRY SCENT ANTI BAC, Ethyl Alcohol Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Carbon Dioxide, USP, Medical Gas Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube … Class IIFDA’s classDec 25, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereArkansas, Kansas and Missouri
- Medicine recall Carisoprodol Tablets, USP 350 mg Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability… Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for Direct Infusion, Baxter… Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured Class IIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Classic Zi Xiu Tang, Bee Pollen Capsule Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Ultimate Formula Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Quick Thin (citrus aurantium extract, sweet potato fiber, cyamopsis gum powder, alfalfa, mulberry leaf,… Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Bethel Advance (bitter orange, mulberry leaf, cassia seed extract, jobstear seed, spirulina, starch, kola… Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall B-50 capsules, 100-count bottles, labeled in part as Healthy Life Chemistry, By Purity First Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereConnecticut, New Jersey and New York
- Medicine recall Multi-Mineral capsules, 200-count bottles, labeled in part as Healthy Life Chemistry, By Purity First Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this product found it to contain undeclared steroid-like substances… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereConnecticut, New Jersey and New York
- Medicine recall Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Evil Root 1200 mg, supplied Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereCalifornia, Florida and Utah
- Medicine recall 72HP MAXIMUM POTENCY MALE SEXUAL ENHANCEMENT, Dietary Supplement, supplied Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereCalifornia, Florida and Utah
- Medicine recall PRO POWER MAX Natural Energy Enhancer, ALL NATURAL HERBS, supplied Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereCalifornia, Florida and Utah
- Medicine recall FOLIC ACID INJECTION, USP Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point Class IIIFDA’s classDec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 25, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall 0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045 Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045 Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 25, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 25, 2013ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Exforge (amlodipine and valsartan Tablets) 5/160 mg Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Exforge (amlodipine and valsartan Tablets) 5/320 mg Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Exforge (amlodipine and valsartan Tablets) 10/160 mg Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Exforge (amlodipine and valsartan, Tablets) 10/320 mg Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician… Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna… Class IIFDA’s classDec 18, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 18, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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